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REQUEST FOR INFORMATION Sterilization of Government Furnished 3D-Printed Swabs, Production of VTM, and Product Sponsorship Objective: This is a Request for Information (RFI) for planning purposes only... REQUEST FOR INFORMATION Sterilization of Government Furnished 3D-Printed Swabs, Production of VTM, and Product Sponsorship Objective: This is a Request for Information (RFI) for planning purposes only. It is not to be construed as a commitment by the Government nor will the Government pay for the information solicited. No solicitation document exists or is guaranteed to be issued as a result of this RFI. The Joint Program Executive Office for Chemical and Biological Defense (Medical Countermeasures Systems) is seeking information on the capabilities and willingness of private entities (academic, non-profit and commercial) in the areas listed below. Background: The novel coronavirus, formally known as COVID-19, is a highly contagious respiratory illness that can spread between people. Symptoms can include a fever, dry cough, body aches and difficulty breathing. In the United States, there are over 374,000 cases of COVID-19 with over 100,000 deaths. Diagnostic testing is an important weapon in the arsenal for controlling COVID, with the preferred sample type being nasopharyngeal collected via a flocked swab. Due to the immense world-wide demand for sampling kits to enable diagnostic testing there are significant shortages of nasopharyngeal swabs and Viral Transport Media (VTM). In response to these shortages, 3D-printed swabs have been developed to supplement supplies. The US Government has the capability to 3D print non-sterile nasopharyngeal swabs, henceforth known as Government Furnished Materials (GFM). The Government requires partners to sterilize this GFM, produce VTM, and potentially assemble the components of this sample collection kit, all compliant with US Food and Drug Administration (FDA) requirements. Requirements: The purpose of this RFI is to solicit information on the availability or developmental status of: Sterilization capacity and capabilities utilizing either autoclaves, gamma irradiation, or other appropriate sterilization method for GFM 3D-printed nasopharyngeal swabs . Ability to produce or aseptically fill VTM or alternative VTM (e.g. sterile saline or PBS) Ability to assemble sterilized GF E3D printed nasopharyngeal swabs and VTM into a sample collection kit As applicable, to be in compliance with the FDA regulations including registration (facility) and listing these sterilized GFM 3D printed nasopharyngeal swabs and/or VTM Industry partners may provide information on individual aspects of these requirements as partnering is encouraged to meet the total desired requirements Performance Objectives: In no more than 5 pages, discuss the performer’s ability to meet the following: Sterilization capacity and capabilities utilizing autoclaves, gamma irradiation, or other appropriate sterilization method for GFM 3D-printed nasopharyngeal swabs. Ability to individually wrap, label, and package government furnished 3D printed swabs as per applicable FDA Quality System Regulations (QSRs) Ability to receive non-sterile materials for sterilization Ability and capacity for sterilizing individually wrapped and labeled 3D printed swabs via autoclaving, gamma irradiation, or other appropriate sterilization method Synopsis of any relevant experience with the FDA regulations such as: Validation studies of the proposed sterilization process The specific procedure(s) for the sterilization process selected and the methods for controlling and monitoring the process. The Device History Records (including process control and monitoring records, acceptance activity records, etc.), as appropriate If the sterilization process is software controlled, details on the software validation Details on personnel qualified and trained to implement the sterilization process. FDA submissions/ marketing authorizations (e.g. 510(k) or DeNovo or Pre-Market Approval), status of facility registration, product listings, and any recent inspections and results. Shelf life (in years) of final products supported by stability studies for similar existing products Estimated cost per individually wrapped, sterilized, labeled, and packaged swab Any associated intellectual property rights or patent coverage ability to produce or aseptically fill VTM or alternative VTM (e.g. sterile saline or PBS), and to be in compliance with required FDA regulations as applicable to general controls or special controls Ability to produce or aseptically fill VTM or alternative VTM (e.g. sterile saline or PBS), and to be in compliance with required FDA regulations as applicable to general controls or special controls Ability to assemble sterilized GFM 3D printed nasopharyngeal swabs and VTM into a sample collection kit, and to be in compliance with required FDA regulations as applicable to general controls or special controls The Respondents shall provide the following in response to this this RFI: 1. Company Description Provide a brief company description and history, emphasizing experience developing and/or sterilizing similar products including other products approved by FDA Provide information related to the company’s quality systems (e.g. ISO 13485 or FDA QSR) Discuss any data rights assertions anticipated for the prototypes Do you anticipate any foreign nationals working on the project? 2. System Description A brief description of the key technology(ies) proposed Visual representation of the end state prototype concept A description of proposed performance characteristics Proposed size and weight Approximate technology readiness level (TRL) upon prototype delivery Ability to meet the performance objectives specified above 3. Cost Provide the Rough Order of Magnitude (ROM) cost estimate of the proposal to develop a sterilization prototype process for further demonstration, testing, and evaluation. 4. Schedule Proposed timeline/schedule to develop prototype process and related technical documentation (technical drawings and build of material) in accordance with the system description. Proposed timeline/schedule to 510(k) clearance for intended use of swabs and/or VTM. Proposed timeline/schedule to sterilize 1.5M swabs once prototype process is developed. Administration: The Government will retain comments and information received in response to this RFI. Proprietary information should be identified as Company Proprietary. Do not use Government security classification markings. All written responses must be received by COB on 16 June 2020. Responses should be sent by e-mail to: usarmy.detrick.jpeo-cbd.mbx.mcs-rfi@mail.mil, with Subject Line of Responding Organization and RFI Title. Material that is advertisement only in nature is not desired. If a solicitation is subsequently released based on the responses to this RFI, posting will either be announced through the Medical CBRN Defense Consortium (MCDC) Other Transaction Agreement (OTA), or issued in compliance with the MCS BAA-17-01, located on beta.sam.gov, keyword “MCS BAA 17-01. Respondents not already members of the consortium are encouraged to join at www.medcbrn.org. Respondents may also inquire about the MCDC at mcdc@ati.org.